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GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors

ConditionLocally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Genhouse Bio Co., Ltd.

About this trial

This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);

Age ≥18 years old, male or female;

KRAS G12C mutant advanced solid tumor;

ECOG Performance Status of 0 or 1

Disqualifiers

acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;

Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;

There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;

Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);

Trial design

Design model

Single group

Treatments tested in this trial

  • GH21

    Drug

    GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule

  • D-1553

    Drug

    D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet

Treatment groups

126 Participants
are divided into 1 treatment group
Group A: "GH21 + D-1553" GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting Toxicities Incidence Count Among Study

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase.

Time frame
2 years
2

Participants Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc

Time frame
2 years

Secondary outcomes

1

response rate (ORR) based on RECIST 1.1 criteria

ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

Time frame
2 years
2

Duration of response (DOR) based on RECIST 1.1 criteria

DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

Time frame
2 years
3

Disease Control Rate (DCR) based on RECIST 1.1 criteria

DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).

Time frame
2 years
4

Progression-free survival (PFS) based on RECIST 1.1 criteria

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Genhouse Bio Co., Ltd.

Lead sponsor

Zhejiang Cancer Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: